Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages,
EU Health Commissioner Stella Kyriakides said last week (January 17).
Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European
Commission's proposal to revise the pharmaceuticals legislation is planned for March.
"Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said.
Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says.
The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides
said.
Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like
antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.
Community Pharmacy England (CPE) has explained MPs on instability that puts operational pressures on pharmacies, financial pressures on businesses at a
Parliamentary drop-in event held on Monday (10 July).
The association has been in Parliament today alongside patient representatives and others to highlight our ongoing concerns about medicines supply to MPs.
It said: "Medicines supply remains a critical issue for community pharmacies with disruption causing problems both accessing medicines and procuring them cost
effectively."
In CPE's recent sector polling, community pharmacy owners rated medicines supply instability as being the most severe pressure facing their businesses. This
echoed the results of CPE's Pressures Survey which found 97% of pharmacy owners survey are facing significant increases in wholesaler and medicine supply issues,
with 71% saying this was leading to delays in prescriptions being issued.
During the Parliamentary drop-in event, CPE talked MPs through the issues and set out what it believe needs to happen to resolve them, calling for- Reform of
Serious Shortage Protocols; Allowing generic substitution; An overhaul of the concessions system; and a strategic Government review of medicine supply and pricing
with a shift to focusing on how to improve the functioning of the supply chain rather than solely on the drive to depress prices and margins.
The National Pharmacy Association (NPA) has asked the Secretary of State for Health and Social Care to convene a 'medicines supply taskforce', following weeks
of problems with antibiotics supplies.
The NPA's chief executive Mark Lyonette wrote a letter to Steve Barclay this week. It cited the precedent of the HRT Taskforce which this summer brought together
representatives from across the supply chain after months of supply problems affecting women.
"We strongly believe that this situation calls for a similar response from the government. It is imperative that we resolve this supply situation urgently and
therefore we request that you convene a Medicines Supply Taskforce, with all the relevant stakeholders in the supply chain, to urgently discuss and agree practical
solutions to address the disruptions to the supply of medicines. HRT and antibiotics are the most visible examples of a wider problem with medicines supply
which needs to be addressed."
NPA board members Olivier Picard and Reena Barai were among the stakeholders joining meetings convened by the HRT Taskforce this summer.
The European Association of Hospital Pharmacists (EAHP) published a shortage supply report on 17 October.
They have officially stated that the shortage has resulted in care delays affecting 58 countries in their recent survey.
It has been found in the report that 59 per cent of pharmacists said medicines shortage had delayed patient care, whereas 43 per cent confirmed it resulted in
suboptimal treatment and 35 per cent said that it had led to the cancellation of care.
András Süle, president of the EAHP spoke on the findings of the report, saying: "Problems caused by medicine shortages remain serious, threaten patient care in
hospitals and require urgent action".
From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among
patients, the government, and the wider pharma industry.
Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine,
and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma
companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February.
The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this
winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like
amoxicillin and Adderall, an ADHD medication.
To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic.
The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply
shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping
containers.
Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution
in times of additional need.
A report released by the Independent Commission has blamed Brexit supply issues for medicine shortages.
NHS is forced to pay extortionate prices to fulfil the demand for vital antibiotics, anti-depressants, Attention Deficit Hyperactivity Disorder (ADHD), and
Hormone Replacement Therapy (HRT) drugs.
The report highlights the impact of affected medicine supply issues on community pharmacies and patients.
Janet Morrison, the chief executive of Community Pharmacy England, backed the report and said that the "medicine shortages and market instability appear to be
as bad as they have ever been".
She also explained how the Ukraine conflict, the COVID-19 pandemic, and broader economic instability also play a major factor in the situation.
A report released by Community Pharmacy England (CPE) has warned that pharmacies across England are grappling with daily medicine supply challenges, posing
significant risks to patients' health.
The Pharmacy Pressures Survey 2024: Medicines Supply Report, which is based on the views of the owners of over 6,100 pharmacy premises in England and 2,000 pharmacy
team members, has exposed some alarming trends concerning medicine supply problems in the country.
Almost all pharmacy team members surveyed (97 per cent) reported patients being inconvenienced due to medicine supply issues, and 79 per cent of the participants
said that the worsening situation is putting patient health at risk.
Nearly all respondents reported patient frustration stemming from medicine supply issues, with 84 per cent of them saying they had experienced aggression from
patients.
Additionally, 98 per cent indicated an increase in 'owings,' where patients receive only part of their prescription and must return to the pharmacy for the
remaining medication(s) at a later time."
There has been extensive national media coverage today (August 11) on how medicine shortages have forced patients to visit multiple pharmacies to get their
prescriptions filled or return to their GP to be prescribed alternative drugs.
These media reports have been based on a survey involving more than 1,500 pharmacists in the UK, in which over a half of those polled said that their patients'
health had been put at risk in the last six months.
In response to a query from Pharmacy Business, the Department of Health and Social Care (DHSC) said it monitors the medicines supply chain closely to prevent any
shortages and acts swiftly when any issue arises.
A DHSC spokesperson told Pharmacy Business: "We take patient safety extremely seriously and we routinely share information about medicine supply issues directly
with the NHS so they can put plans in place to reduce the risk of any shortage impacting patients, including offering alternative medication.
A recent report by the British Generic Manufacturers Association (BGMA) has shed light on ongoing supply challenges in England's generic medicines market,
revealing significant issues impacting patient care.
The report highlights significant challenges faced in supply of medicines as currently, 51.72 per cent of generics in short supply lack licensed alternatives,
posing substantial hurdles to ensuring continuous patient care.
Additionally, 39.08 per cent of affected generics are branded, indicating widespread disruptions across the market.
A notable 26.44 per cent of generics experiencing shortages have been affected for over six months, highlighting persistent difficulties in supply chain management.
The report indicates that 0.15 per cent of generic medicine presentations listed in the Drug Tariff are currently facing supply issues, impacting accessibility
nationwide.
The Department of Health and Social Care (DHSC) has allowed pharmacists to supply alternative penicillin to treat Strep A. It has issued Serious Shortage
Protocols (SSPs) for three penicillin medicines.
"The SSPs will help mitigate local supply issues of oral penicillin and allow pharmacists to supply alternative forms of the medicine if they do not have the
specific formulation stated on the prescription," said DHSC.
SSPs have been issued across the UK for 3 penicillin medicines on Thursday (December 15.
"Issuing an SSP allows pharmacists to legally supply a specified alternative medicine, removing the need for the patient to return to the prescriber - which saves
time in GP practices and inconvenience for patients."
"Demand for penicillin has risen recently as it is used to treat strep A and scarlet fever, and the increased demand means that some pharmacists are experiencing
temporary and localised supply issues and may not have the specific formulation listed on the prescription."
The British Generic Manufacturers Association (BGMA) on Monday alerted the Health and Social Care Committee that medicines shortages have increased and
are "around double what they were a year ago."
BGMA chief executive Mark Samuels told the committee that they have been highlighting the medicine shortage risk to ministers since July 2021 and the association
is "very concerned" about the current situation.
"We've been monitoring it for several years now, and as you saw in the written evidence, shortages have increased. They're around double what they were a year ago.
We have them at 101 shortages in February this year," said Samuels.
Dr Rick Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), highlighted that the problem of drug
shortages in the UK is a "long-standing issue" and the scarcity of certain medications "continues to be challenging".
People who use pharmacies in parts of Pendle have suffered shortages or delays in buying prescription medicines such as insulin, councillors have been told.
In the Barnoldswick area, a number of pharmacies have been impacted and some councillors hope a new regional NHS organisation might look into the problems.
However, pharmacies in the neighbouring town of Nelson are facing shortages with other medicines. A pharmacists in Nelson Pharmacy told Pharmacy Business that he
was struggling to meet local demand for children's paracetamol due to ongoing shortages.
Pendle Council's West Craven Area Committee heard about the issues at its latest local meeting, held in Earby.
An agenda for the committee stated: "Pharmacy provision in West Craven. It is reported that there is an acute problem with people being unable to get prescriptions
filled, with Whitworth chemists suffering a breakdown in service. Previously, Well chemists has suffered similar problems."
Speaking at the meeting, Lib-Dem Coun David Whipp said: "It's quite an appalling situation where people are queuing 30 minutes to get a prescription filled but when
they get to the counter they are told it's not ready. They have to go home and come back at 5pm. It's an ongoing problem.
"It includes insulin, which is critical for people with diabetes. I know several people who have failed to get insulin, It's a very serious problem."
He added: "I think the committee should contact the local integrated care service. I think they are responsible for primary care which includes pharmacies. We need
to find out what's happening and improve things in future. "
Switzerland is experiencing medicine shortages due to supply chain issues linked to COVID lockdowns in China and war in Europe, the country's pharmacists
association said.
"We have the biggest problems with children's medications, especially fever-reducing syrup," Enea Martinelli from pharmaSuisse told Swiss broadcaster SRF.
"There are also shortages of blood pressure medications, psychiatric medications and Parkinson's medications," he said.
The European Commission launched an initiative to deal with the ongoing supply crisis on Tuesday (24 October).
The following announcement comes after the shortage of key antibiotics last winter identified by the European Health Emergency Preparedness and Response
Authority (HERA) and the European Medicines Agency (EMA).
The "European Voluntary Solidarity Mechanism" is a proposed short-term measure that involves a Member State's need for a given medicine to other Member States
to redistribute medicines from their available stock.
Additionally, the Commission intends to cooperate with member states to improve components of pharmaceutical reform with an aim to strengthen supply security.
They are setting up a few actions apart from the launch, a list of critical medicines to analyse the supply chain by early 2024; regulatory flexibilities;
strengthening security of supply; and availability of antibiotics and treatments for respiratory viruses by next winter.
Following Community Pharmacy England's Parliamentary drop-in event on medicines supply issues last week, several MPs have since raised questions to the Health
Secretary during a Health Questions session on July 18th.
According to CPE, MPs from all Parties displayed great engagement with the current pressures facing community pharmacies, particularly regarding medicines supply
issues.
During last week's event, Mike Amesbury, the MP for Weaver Vale, was present and directed a question to the Health Secretary: "Eighteen community pharmacists in my
constituency are reporting challenges with medicine supplies. What further actions will the Minister take to address and resolve this situation effectively?"
In response, Health Secretary Steve Barclay MP stated, "We have a dedicated team in the Department that focuses on medical supplies, which are an ongoing concern.
Challenges in this area are a routine part of our business."
The British Generic Manufacturers Association (BGMA) has raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent.
The Department of Health Social Care (DHSC) today announced that the 2019 voluntary scheme payment percentage for 2023 will be 26.5%. The 2019 voluntary scheme
for branded medicines pricing and access is an agreement between the Department of Health and Social Care, NHS England and the Association of the British
Pharmaceutical Industry.
BGMA believes that the high VPAS tax for 2023 risks more medicines shortages, rising prices for the NHS via reduced competition, and new medicine launches to the
UK being deferred.
Mark Samuels, Chief Executive of BGMA, said: "Raising the VPAS tax to 26.5% will damage the UK's medicines supply because it will make some products lossmaking. It
is more than a five-fold tax increase from 2021, and no industry can cope with this unpredictable and exceptional tax volatility.
The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot
be hoarded or exported from the UK market.
The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs.
In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to
patients across the UK.
The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.
In a recent meeting with the head of the government's HRT Taskforce, Madelaine McTernan, the National Pharmacy Association (NPA) board members gave a gist on the ongoing medicines supply issues in community pharmacy.
The meeting, which explored possible solutions to end the nationwide shortage of some Hormone Replacement Therapies, took place on Friday (May 20).
Independent contractors Reena Barai and Olivier Picard gave the so-called 'HRT tsar' an overview of the medicines supply issues in community pharmacy and discussed the new Serious Shortage Protocols (SSPs) which the government introduced in response to the on-going HRT disruption.
Earlier this month, the NPA attended an HRT summit organised by the Department of Health and Social Care, alongside other pharmacy bodies, wholesalers and manufacturers.
Health secretary Sajid Javid and pharmacy minister Maria Caulfield said they would be working collaboratively with manufacturers to meet demand and boost supply.
In the parliamentary drop-in-event hosted by Community Pharmacy England last week, Members of Parliament (MPs) questioned the Health Secretary on the rising
issue of medicines supply.
"Eighteen community pharmacists in my constituency are reporting challenges on medicine supplies. What more is the Minister going to do to get a grip of this
situation?", Mike Amesbury MP for Weaver Vale, who was present at the event last week, asked the Health Secretary.
In his response, the Health Secretary, Steve Barclay MP said: "We have a long-standing team in the Department focused on medical supplies, which are a continual
issue; as a matter of routine business, there are often challenges in that area."
The Shadow Pharmacy Minister, Karin Smyth MP, also asked: "People across the country rely on local, accessible pharmacies, but whether it is high street closures
or supply problems leading to the absurd situation where women are phoning or visiting multiple pharmacies for a prescribed dose of hormone replacement therapy and
other drugs…They have repeatedly announced plans to expand the role of community pharmacies but have failed to update legislation that could possibly help. … Why
will they not do so?
The Pharmaceutical Services Negotiating Committee (PSNC) has expressed its concerns over sustained pressures on medicines supply that are having a very
serious impact on community pharmacy teams and their patients.
It has asked contractors and their teams to continue using its regular reporting tools to help them demonstrate the scale of the problems to the Department of
Health and Social Care (DHSC) and to support escalations as needed.
The committee said: "The sustained increases in price concessions that we have seen so far in 2022 - with more than 100 concessions being granted in some months -
show no signs of abating, and we know that many pharmacies now find themselves in a critical situation trying to source medicines in timely manner and facing
significant financial risk due to greater uncertainty around expected reimbursement prices for a large number of medicines."
"We know that some concessions being imposed by the Department do not match contractors' experience on the ground, and we would ask all contractors to continue
reporting pricing issues to us on a regular basis to support our representations: Report product over Drug Tariff price."